FDA to release guidance on generic tablet size
Posted 17/06/2011

The FDA hopes to release guidance in the next few months to help generic drug makers understand how big or small their tablet or capsule can be compared to the branded equivalent, an agency official said.

The FDA has received repeated questions from industry and has seen enough issues with improper tablet size in generic drugs that the agency has drafted guidance on the topic. Mr Peter Rickman, Director of the Office of Generic Drugs, Division on Labeling and Program Support said ‘we really want the generic product to look the same as the innovator as much as possible’.

It makes sense that patient compliance could be improved during generic substitution if the generic mimicked the originator tablet/capsule more closely. Patients in recent studies have commented that it was difficult to know which drugs were replacing which, due to different shapes, colours and packaging [1].

Editor’s comment

This is perhaps something the generics industry needs to bear in mind when producing generics of well-known originators. Convenience for the patient, especially elderly ones with reduced eyesight, will certainly go a long way to improving patient compliance and increasing acceptance of generic drugs.

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on whether generic drugs should look the same – shape, size, colour – as the originator? How do you think this would affect (aid/hinder) the generics industry?